BAYER: Kerendia™ (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study / FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D, and demonstrated that Kerendia significantly reduced the risk of CV events in adult patients with CKD and T2D versus placebo / The extended EU-label for Kerendia now reflects data from more than 13,000 patients with CKD and T2D, based on the Phase III FIDELIO-DKD and FIGARO-DKD studies




erlin, February 10, 2023 – The European Commission granted approval for a label extension for Kerendia™ (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. The indication of Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, has been extended to include early stages* of CKD associated with T2D. Kerendia is now indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults.



Results from the pivotal Phase III FIGARO-DKD study were presented at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine. FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D. The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D versus placebo.



"Patients with chronic kidney disease are faced with an increased risk of cardiovascular events," said Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. "As chronic kidney disease progresses silently, with oftentimes no symptoms in the early stages, patients with type 2 diabetes should be regularly monitored by their doctor for the earliest signs of kidney disease, and once diagnosed should be treated comprehensively to reduce the risk of cardiovascular complications and death."



Mineralocorticoid receptor (MR) overactivation contributes to CKD progression and CV damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Addressing an alternative pathway, Kerendia offers protection as it selectively binds to the MR receptor, blocking harmful effects of MR overactivation.



"Even when blood glucose levels and blood pressure are well-controlled, the risk of kidney disease progression and cardiovascular events remains high in patients with chronic kidney disease and type 2 diabetes," said Dr. Michael Devoy, Chief Medical Officer of Bayer’s Pharmaceuticals Division. "Kerendia addresses a key cause of disease progression that is not addressed by other therapies, and offers physicians a distinct path to protect patients from further kidney damage and cardiovascular events. With Kerendia having demonstrated kidney and cardiovascular benefits across a broad spectrum of disease severity in the pivotal Phase III studies, today’s approval of the label extension supports the use of this drug also in patients with earlier stages* of chronic kidney disease associated with type II diabetes."



Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted initial marketing authorization by the European Commission in February 2022 for the treatment of CKD (stage 3 and 4 with albuminuria) associated with T2D in adults. Following this approval by the European Commission, the extended EU label for Kerendia now reflects data from more than 13,000 patients with CKD and T2D, based on both the Phase III FIDELIO-DKD and FIGARO-DKD studies.



About Kerendia™ (finerenone)
Kerendia is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.



Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia™ was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2021, the European Commission in February 2022, and the Chinese National Medical Products Administration (NMPA) in June 2022. In September 2022, Bayer announced that it received approval from the U.S. FDA for a label update for Kerendia™ to include findings from the Phase III FIGARO-DKD CV outcomes study. In February 2023, based on the Phase III FIGARO-DKD findings, Kerendia™ received approval from the European Commission for a label extension, to include early stages of CKD associated with T2D. Based on the positive results of both pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD, Kerendia™ was approved in March 2022 by the Japanese Ministry of Health, Labour, and Welfare (MHLW). Further regulatory approvals by other health authorities in multiple other countries have been granted or are currently pending following submissions for marketing authorization.



The Phase III study program with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD, and FIONA, as well as the Phase II study CONFIDENCE.



Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, FIDELIO-DKD and FIGARO-DKD, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.



The prespecified FIDELITY pooled analysis, including the FIDELIO-DKD and FIGARO-DKD studies, investigated the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D in reducing the risk of chronic kidney disease progression as well as fatal and nonfatal CV events and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes – KDIGO – risk categories) and the effects of finerenone on composite cardiovascular and kidney-specific endpoints.



About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 190 million people with T2D worldwide. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive.Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.



About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.



About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special



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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

 

The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack involving up to 30,000 patients / Bayer drives the development of its FXIa inhibitor, with the goal of offering a potential new class of antithrombotics for improved outcomes for patients using selective coagulation modulation

 

Bayer is on the right track” Operationally and strategically successful in 2021 / Dividend of 2.00 euros per share proposed / Very successful start to 2022

Leverkusen, April 29, 2022 – The Bayer Group was operationally and strategically successful in 2021. “We achieved a lot, and there is a lot of good news to report as regards our operational performance, innovation power and sustainability. Bayer is on the right track,” said Werner Baumann, Chairman of the Board of Management, at the company’s virtual Annual Stockholders’ Meeting in Leverkusen on Friday. Bayer has also got off to a very successful start to 2022, he added. “In the agriculture business in particular, we see a much more positive market environment than in previous years. We believe the strategic alignment of our company has proven to be the right one. That is also true when it comes to our societal relevance. People will be able to count on Bayer to support the global food supply. We are guided by our vision ‘Health for all, hunger for none.’ And we have still been able to successfully manage our business under these difficult conditions as well,” Bayer’s CEO reported in reference to the war in Ukraine. Bayer had originally announced that 2021 would be a year of transition, but the company exceeded the Group forecast even after raising it twice. Sales advanced to 44.1 billion euros. EBITDA before special items fell by 2.5 percent to 11.2 billion euros. Bayer was able to largely offset an increase in the cost of goods sold – partly inflation-related – as well as significant currency headwinds. Core earnings per share from continuing operations of the Group rose by 1.9 percent to 6.51 euros. As Bayer is maintaining its dividend policy of distributing between 30 and 40 percent of core earnings per share, the Board of Management and the Supervisory Board have proposed to the Annual Stockholders’ Meeting that a dividend of 2.00 euros per share be paid for fiscal 2021. Baumann joined Supervisory Board Chairman Norbert Winkeljohann in thanking the company’s employees around the world. “They are the ones who achieved and enabled all of this. They did so with the tremendous passion and motivation that make our Team Bayer what it is.” However, Baumann was not satisfied with the performance of Bayer’s share price in 2021. “Nonetheless, the situation has improved in recent months. Since the beginning of the year, the price of our shares has increased more than 30 percent! That is by far the best performance among DAX and EuroStoxx 50 companies during this period!”

BAYER: Water and soil are vital. Our most recent innovations are reducing the environmental impact of agriculture and preserving these natural resources.

 

Water and soil are vital. Our most recent innovations are reducing the environmental impact of agriculture and preserving these natural resources.

Discover more:https://t.co/OxGvvBt8iW

— Bayer AG (@Bayer) March 21, 2022

 

Bayer to sell its Environmental Science Professional business to Cinven for 2.6 billion U.S. dollars

Transaction streamlines Crop Science portfolio and ensures greater focus on core agricultural business / Cinven seeks to continue to drive innovation and accelerate growth through significant investment in the acquired business

Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data Raise in peak sales expectations follows presentation of positive Phase III trial ARASENS with darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer at 2022 ASCO GU Cancers Symposium and publication in The New England Journal of Medicine on February 17, 2022 / Broad development program underway with three additional ongoing or planned large clinical studies for darolutamide across a broad spectrum of prostate cancer

Berlin, February 17, 2022 – At the 2022 ASCO GU Cancers Symposium Bayer presented results from the Phase III ARASENS trial which demonstrated that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001). At the data cutoff date for the primary analysis (October 25, 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months). Amid these positive results Bayer raised peak sales expectation for Nubeqa™ (darolutamide) to exceed €3 billion. “Subject to regulatory approval, the team at Bayer is excited to be able to offer even more patients suffering from prostate cancer an additional treatment option backed by strong clinical data,” said Stefan Oelrich, Member of the Board of Management of Bayer and President of the Pharmaceuticals Division. “With the confirmation of darolutamide’s clinical profile and expansion into the metastatic setting as well as the investments that we are making in clinical trials in other potential indications, we feel that Nubeqa has the potential to generate peak sales of more than 3 billion euros”. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Based on results from the pivotal Phase III ARAMIS trial, the compound is already approved for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease, in more than 60 markets worldwide. Results from the second Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) were presented yesterday as an oral presentation at the 2022 ASCO GU Cancer Symposium and simultaneously published in The New England Journal of Medicine. Bayer is already in discussions with health authorities worldwide regarding the submission for marketing authorization in this additional indication. Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov. In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned. About Nubeqa™ (darolutamide) Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS and ARASENS Phase III trials and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial. The product is approved under the brand name Nubeqa™ in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also currently being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

Bayer highlights advancements of agriculture industry’s most prolific R&D pipeline

Crop Science R&D Pipeline Update 2022

Bayer highlights advancements of agriculture industry’s most prolific R&D pipelineIndustry-leading investment expected to translate to nearly €30bn peak sales potential / Game-changing Short Stature Corn advances, readying for 2023 commercial trials / More than 500 new high-performing seed hybrids and varieties deployed and greater than 300 new registrations refresh crop protection portfolio / Digital transformation well underway as Climate FieldView™ reaches more than 180 million acres; unlocks climate-smart models with expansion of Bayer Carbon Initiative

 Bayer showcases the latest in crop protection, seeds & traits and digital solutions. ...

Bayer will discontinue phase II development candidate eliapixant

Bayer will discontinue phase II development candidate eliapixantReview of development program led to reassessment of benefit-risk ratio in all four potential indications for the investigational P2X3 receptor antagonist


Berlin, Germany, February 4, 2022 – Bayer today announced the discontinuation of Phase II development candidate eliapixant (BAY 1817080), an investigational P2X3 receptor antagonist that was being evaluated for potential indications in endometriosis, refractory chronic cough, overactive bladder and diabetic neuropathic pain. Following a review of available data, Bayer concluded that the overall benefit no longer outweighs the risk in these indications.

Eliapixant is an investigational agent and has not been approved for use in any country, for any indication.

BAYER: Leaps by Bayer leads $80M Series A Financing for Cellino Biotech to Autonomize Stem Cell Therapy Manufacturing

 

Leaps by Bayer leads $80M Series A Financing for Cellino Biotech to Autonomize Stem Cell Therapy Manufacturing

Cellino aims to significantly expand patient access to stem cell-based therapies with autonomous end-to-end manufacturing / Proceeds will expand machine learning, software, and hardware capabilities and to develop early-stage Good Manufacturing Practice (GMP) capabilities to support clinical trials, with plans to build the first autonomous human cell foundry in 2025 / Investment further strengthens existing company portfolio of Leaps by Bayer in the fields of cell and gene therapies


Cambridge, MA, US and Leverkusen, Germany / January 25, 2022 – Cellino Biotech, Inc., an autonomous cell therapy manufacturing company, today announced the completion of a Series A financing of $80 million, led by the impact investment arm of Bayer AG – Leaps by Bayer – 8VC, and Humboldt Fund. New investors in the round include Felicis Ventures and others, joining existing investors The Engine and Khosla Ventures. The company has raised a total of $96 million i

BAYER:U.S. FDA approves Xarelto™ to treat venous thromboembolism (VTE) and to prevent VTE in children

 

U.S. FDA approves Xarelto™ to treat venous thromboembolism (VTE) and to prevent VTE in children

Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing / Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age / Convenient liquid formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives   ... ... ... ... Blood clots ... ... ... ...

Berlin, December 21, 2021 – The U.S. Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto™ (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.

Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease

For children and adolescents with chronic kidney disease (CKD), as for adults, the unmet need is high for new treatments to delay disease progression and preserve kidney function / The Phase III study FIONA will investigate the effect of finerenone in pediatric patients with CKD and severely increased proteinuria

Berlin, November 15, 2021 – Bayer announced today the initiation of the FIONA study, a multicenter, randomized, double-blind, placebo-controlled Phase III study, to investigate the efficacy, safety and pharmacokinetics/pharmacodynamics (PK/PD) of finerenone, in addition to standard of care, for the treatment of pediatric patients with chronic kidney disease (CKD) and severely increased proteinuria. The primary objective of the study is to demonstrate superiority of finerenone in addition to an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) over placebo in reducing urine protein excretion in these patients. The primary outcome measure is the change in urine protein creatinine ratio (UPCR) from baseline to 6 months.

“Chronic kidney disease is a rare but devastating condition affecting children across the age spectrum. Despite some progress achieved through previous research efforts, children with this condition continue to experience disease progression and proteinuria – an important, modifiable risk factor for kidney function decline. New treatments are needed to target this risk factor whilst working synergistically with current therapies,” said Dr. Franz Schaefer, Professor of Pediatrics and Chief of the Pediatric Nephrology Division at Heidelberg University Hospital. “If successful, insights from this study could be of great significance to children living with chronic kidney disease and their families.”

Proteinuria is an important modifiable risk factor for CKD progression in children. Aldosterone-mediated activation of mineralocorticoid receptors (MR) in the kidney drive the downward spiral by promoting tissue inflammation and injury. Finerenone is an investigational, non-steroidal, selective MR antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation, which is thought to contribute to CKD progression and cardiovascular damage.

Finerenone has been investigated in a broad population of adult patients with stages 1-4 CKD and type 2 diabetes (T2D) across two completed Phase III studies: FIDELIO-DKD and FIGARO-DKD. In these studies, finerenone demonstrated benefits on kidney and cardiovascular outcomes in patients with CKD and T2D. Finerenone demonstrated a consistent safety profile across studies. FIDELITY, a pre-specified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in more than 13,000 patients with CKD and T2D, evaluated the potential benefit of finerenone across the disease spectrum.

“In the largest Phase III clinical trial program to date in chronic kidney disease and type 2 diabetes, which included more than 13,000 adult patients, finerenone has demonstrated the potential to improve kidney and cardiovascular outcomes,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The new FIONA study extends our clinical research for finerenone to children and adolescents with chronic kidney disease, where the unmet need is high for new treatments to delay disease progression and preserve kidney function as much and for as long as possible.”

The planned Phase III FIONA study will investigate finerenone compared to placebo in addition to standard of care in approximately 200 patients with CKD. Patients will be randomized in a 2:1 ratio to receive either a body-weight adjusted dose of finerenone or placebo on top of individually optimized labeled doses of either ACE inhibitors or an ARB. The FIONA study will contribute to the IMI2 conect4children (c4c) project, by utilising the c4c network and its clinical sites across Europe. c4c aims to provide better medicines for babies, children and young people by improving the way clinical trials are planned and conducted across Europe. In addition, the study will be conducted in collaboration with two pediatric CKD-specific clinical research networks, ESCAPE (European Study Consortium for Chronic Kidney Disorders affecting Pediatric Patients) and NAPRTCS (North-American Pediatric Renal Trials and Collaborative Studies).

In July, finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study for adult patients with CKD and T2D. Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide; these applications are currently under review.

About Finerenone
Finerenone (BAY 94-8862) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation. MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors.

The Phase III study program with finerenone, FINEOVATE, currently comprises five Phase III studies: FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and FIONA.

The initiation of the Phase III FIONA study (FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA) builds upon the robust Phase III results from the FIDELIO-DKD and FIGARO-DKD studies which evaluated the effects of finerenone versus placebo on top of standard of care across a broad range of disease severity, on both renal and cardiovascular outcomes in patients with CKD and T2D. Based on these findings, FIONA will investigate the effect of finerenone in pediatric participants with CKD and severely increased proteinuria.

The initiation of the Phase III FIND-CKD study (FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease) builds upon the robust Phase III results from the FIDELIO-DKD and FIGARO-DKD studies which evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes in patients with CKD and T2D. Based on these findings, and since the beneficial kidney effect of finerenone observed in previous studies was independent of the glycemic state and was shown in a related population, FIND-CKD will investigate the effect of finerenone in patients with non-diabetic etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys).

About Chronic Kidney Disease in Pediatric Patients
Globally, between 30 and 90 children per million have CKD stage 2 or higher. The annual incidence in European countries ranges from 8.7 to 17.5 cases per million children. As in adults, secondary treatment strategies for CKD in children aim to prevent disease progression by focusing on control of blood pressure and proteinuria through RAAS blockade with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB). However, despite treatment with available standard ACEI or ARB therapy, pediatric patients with CKD, like adults, continue to have proteinuria and progression of renal disease. Therefore, novel treatment options are needed which target modifiable risk factors, and act synergistically with the established therapies to overcome their limitations and improve the outcome in children with CKD.

IMI2 conect4children
The Collaborative Network for European Clinical Trials for Children (conect4children or c4c) is an action under the Innovative Medicines Initiative 2 (IMI2) Joint Undertaking (https://www.imi.europa.eu/), Grant Agreement 777389.

IMI2 c4c aims to enhance the development of better medicines for babies, children and young people, by generation of a sustainable infrastructure across Europe, that optimizes the delivery of clinical trials in children, and the use of innovative trial designs and new quantitative methods.

About ESCAPE
The ESCAPE Network (European Study Consortium for Chronic Kidney Disorders Affecting Pediatric Patients) is a group of 30 pediatric nephrology expert centers from 9 European countries. The Network aims to improve the management of chronic kidney disease in children and adolescents and has performed numerous clinical trials and cohort studies over more than two decades. In the landmark ESCAPE Trial, the consortium established the efficacy of strict blood pressure control and ACE inhibition in slowing renal failure progression in children. Further information on the ESCAPE Network can be found at http://www.escapenet.eu.

About NAPRTCS:
The North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) is a multicenter, registry-based research effort. NAPRTCS has partnered with industry sponsors since 1994 to conduct clinical trials to advance knowledge about pediatric kidney disease and to study best practices for treatment of various pediatric kidney disorders. Further information on NAPRTCS can be found at https://naprtcs.org.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

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